Status:
COMPLETED
Total Marrow Irradiation for Refractory Acute Leukemia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
Up to 55 years
Phase:
PHASE1
Brief Summary
RATIONALE: Giving chemotherapy and total marrow irradiation before a donor umbilical cord blood or hematopoietic stem cell transplant helps stop the growth of cancer cells. It may also stop the patien...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of total marrow irradiation (TMI) delivered by image-guided tomographic intensity-modulated radiotherapy when administered in combination w...
Eligibility Criteria
Inclusion
- Acute lymphoblastic leukemia
- ≥ Complete remission 2 (CR2) (adults ≥ 18 years and ≤ 55 years)
- CR2 in pediatrics (defined as \<18 years) and \<12 months duration of first remission
- ≥ CR3 or not in remission (pediatric patients \<18 years)
- T cell leukemia ≥ CR2
- Evidence of pre-transplant minimal residual disease (MRD) by flow cytometry, FISH or cytogenetics
- Myelodysplastic syndrome
- ≤ 55 years of age and ≥ 10% blasts, not responsive to hypomethylating agents and/or conventional therapy
- Acute myeloid leukemia
- Not in remission (pediatric patients \<18 years)
- Not in remission (10-30% blasts in the bone marrow for adult patients ≥18 years and ≤ 55 years)
- Evidence of pre-transplant minimal residual disease (MRD) by flow cytometry, FISH or cytogenetics
- Multiple myeloma
- No prior autologous transplant and fitting into one of the following disease categories:
- Early disease stage (CR1/PR1) with high-risk molecular features
- Early disease stage (CR1/PR1) with high-risk clinical features
- Late disease stage (CR2/PR2+) with high-risk clinical features
- Other high risk hematologic malignancies - to be approved by 2 or more hematology/oncology and BMT physicians
- Patients with prior CNS involvement are eligible provided that it has been treated and is in remission. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the protocol.
- Have acceptable organ function within 14 days of study registration defined as:
- Renal: glomerular filtration rate \> 60ml/min/1.73m2
- Hepatic: bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Alkaline phosphatase (ALP) \< 5 x upper limit of normal (ULN)
- Pulmonary function: Carbon Monoxide Diffusing Capacity corrected (DLCOcorr) \> 50% of normal, (oxygen saturation \[\>92%\] can be used in child where pulmonary function tests (PFT's) cannot be obtained)
- Cardiac: left ventricular ejection fraction ≥ 45% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
- Karnofsky performance status (PS) \>80% for ages 16 years and older or Lansky Play Score \>50 for \< 16 years
- An acceptable source of stem cells according to current University of Minnesota BMT program guidelines:
- UCB graft will be composed of two partially HLA matched units. Each unit must be matched at 4-6 HLA loci to the recipient and to each other. If two matched units are not available, then a single HLA 4-6 matched unit may be used if of adequate cell dose - total graft dose must be \>3 x 107 MNC/kg
- HLA-matched related donor (6/6 or 5/6 antigen match)
- HLA-matched unrelated adult donor (if previously identified)
- Women of childbearing potential must agree to use adequate contraception (diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration of treatment.
- Voluntary written consent
Exclusion
- Active uncontrolled infection at time of enrollment or documented fungal infection within 3 months.
- Evidence of Human immunodeficiency virus (HIV) infection
- Pregnant or breast feeding. The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy.
- Prior myeloablative transplant within the last 6 months
- Prior total body irradiation (TBI) making total marrow irradiation (TMI) not feasible
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00686556
Start Date
August 1 2012
End Date
December 1 2016
Last Update
December 5 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455